CorMedix Inc.

Good morning and welcome to the CoreMedx Inc. third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Daniel Ferry from LifeSci Advisors, Thank you, and over to you.

Good morning, and welcome to the Corps Medics third quarter 2022 earnings conference call. Leading the call today is Joe Tedisco, Chief Executive Officer of Corps Medics, and he is joined by Dr. Matt David, Executive Vice President and CFO, Dr. Phoebe Mounts, EVP, General Counsel, and Head of Technical Operations, Aaron Mistry, SVP of Commercial. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meeting set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following. Any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program, manufacturing activities, and NDA approval for DefendCath in the U.S. or other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of DefendCath or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, progress, results, estimates, and interpretations thereof, projections as to the company's future capital raising and spending and cash position, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development or other transactions, any commercial plans and expectations, market projections for our current product candidates, and expectations as to manufacturing and product component costs. Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization. These risks are described in greater detail in CoreMedix filings with the SEC, including the latest 10-Q filing, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CoreMedix. CoreMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Please note that Corps Medics does not intend to update these forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of Corps Medics. Joe, please go ahead.

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. Over the last three months, the company has continued to make excellent progress on all fronts, working diligently in support of our CMO as they implement corrective action to the deficiencies received during a June FDA inspection, as well as undertaking multiple steps to build out the team, processes, and systems to be ready for commercialization as quickly as possible following a potential FDA approval. While Phoebe will provide a more detailed regulatory update and specifics around potential resubmission timing, I am very pleased with the efforts undertaken by our CMO these last three months to address the concerns cited by FDA during the site inspection as well as the work our team is doing to mitigate compliance risk by creating alternative supply chain options for resubmission. My goal is to secure final FDA approval of the DefendCath MDA in 2023, and we are mobilizing all resources needed to increase our probability of success. From a commercial standpoint, in addition to building out systems and processes for commercial operation, we are actively engaged in multiple prelaunch activities, such as disease state education and awareness, key opinion leader engagement, and early-stage strategic discussions with key customers, such as large health systems and IDN. This past week, the company exhibited and presented an abstract at the American Society of Nephrology annual meeting, which took place during Kidney Week. The abstract highlighted data generated by Chormetics during a retrospective analysis of data pulled from multiple clinical and claims databases that track kidney failure patients. Our analysis highlighted the significant incidence of and morbidity and mortality associated with catheter-related bloodstream infections, or CRBSIs, in catheterized hemodialysis patients. As the company broadens its presence at upcoming medical conferences and events, we intend to bring attention to the high incidence and severity of CRBSIs in the hemodialysis community, a critical unmet medical need for which to FENCAS can be a solution. During our last earnings call, we were happy to announce that the Center for Medicare and Medicaid Services, or CMS, published in the Federal Register the Conditional New Technology Add-on Payment, or NTAP, reimbursement for DefendCast. This past Monday, we were also happy to announce that CMS published in the Federal Register a revised NTAP, increasing the upper limit of reimbursement from $4,387.50 per average hospital stay to $14,259.38. The original NTAP calculation from CMS was based upon three vials of DefendCath utilized for catheter lock during three dialysis sessions. The revised NTAP is based upon a longer duration of hospital stay in which an average of 9.7 vials of DefendCath would be utilized. The NTAP for DefendCath is calculated by CMS as 75% of the expected wholesale acquisition cost or WAC of the product and is conditioned upon final FDA approval of the DefendCath NDA prior to July 1st of 2023. While CoreMedix is working to obtain NDA approval as quickly as possible, to mitigate the risk of approval delay beyond the July 1st cutoff, the company also recently announced the submission of a duplicate NTEP application to CMS, which would be applicable should the company obtain NDA approval after July 1st of 2023. As the criteria to obtain an NTAP are objective in nature, and the company successfully met the criteria during the last application, and the criteria have not changed, the company expects to remain eligible to receive NTAP for DefendCAS should NDA approval occur after July 1st of 2023. The inpatient segment, though smaller than the outpatient segment in terms of lumen lock volume, has substantial potential dollar value due to higher price elasticity in comparison to the outpatient segment. The inpatient segment is not only plagued by high incidence of CRBSIs in its catheterized hemodialysis population, but there is an extremely high readmission rate for recurring CRBSIs within 30 days. The combination of high incidence and high readmission rates for recurring infections result not only in adverse patient outcomes, but adverse financial outcomes for hospitals and health systems. The fallout from the high incidence and re-emission rates, coupled with the NTAP reimbursement to the healthcare facilities, provide a compelling justification for meaningful inpatient utilization and uptick. As the initial phase of our launch will focus heavily on the inpatient market segment, securing NTAP, and CMS subsequent revision of the upper limit, is a significant value driver for DFENCAP and essential to driving market uptake. While our NCAP is specific to inpatient reimbursement, we continue to take a two-pronged approach with respect to outpatient reimbursement. First, we remain committed to our efforts to secure a transitional drug add-on payment adjustment, or TdAPA, as soon as practical after securing our anticipated FDA approval. TdapA is an incremental payment to the Renal Dialysis Service Bundle allocated by CMS to outpatient dialysis clinics. While we do see TdapA as a viable reimbursement pathway to drive utilization of DefendCast, we believe there are compelling arguments that DefendCast does not fall within the scope of products and services calculated as part of the dialysis bundle under the current statute, and therefore should be reimbursed separately by CMS as an outpatient drug product with a unique J-code. We believe a unique J-code and separate reimbursement better incentivizes dialysis operators to utilize the product for the betterment of patient outcomes. To be clear, any decision to separately reimburse DefendCath or grant DefendCath to DAPA is ultimately at the sole discretion of CMS, but we will be working diligently over these next few months along with other key stakeholders, such as dialysis operators, health systems, and patient advocacy groups to make these arguments to CMS. Final FDA approval of DFENCAP is required before we are able to submit a formal application for DADAPA or a unique J-code, and the estimated timing to a decision from CMS is approximately six months from submission of the application in both instances. At this time, I'd like to turn the call over to Phoebe, who will provide an update on regulatory affairs and manufacturing. Phoebe?